Study period | Screening | Baseline | Treatment | Follow-up | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Study day (± window) | 0-1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 10 | 11-27 | 28 (±3) |
ELIGIBILITY | |||||||||||
(Deferred) Informed consent | X | ||||||||||
Demographics | X | ||||||||||
Relevant medical history | X | ||||||||||
SARS-CoV-2 diagnostic test review | X | ||||||||||
Assess ARDS diagnosis and severity | X | ||||||||||
Inclusion and exclusion criteria | X | ||||||||||
STUDY INTERVENTION | |||||||||||
Randomization | X | ||||||||||
IMP administration | X | X | X | X | X | X | X | ||||
Treatment with SoC | X | X | X | X | X | X | X | X | X | X | X |
STUDY PROCEDURES | |||||||||||
12-lead Electrocardiogram | X | X | X | X | X | X | |||||
Height and weight | X | X | |||||||||
Targeted physical examination | X | X | X | X | X | X | X | ||||
Vital signs: temperature, pulse rate, blood pressure, respiratory rate, SpO2 and FiO2 | X | X | X | X | X | X | X | X | X | ||
Placement of central venous catheter and PiCCO catheter | X | ||||||||||
EVLWi and PVPi | X | X | X | X | |||||||
Mechanical ventilation parameters(i) | X | X | X | X | X | X | |||||
Arterial blood gas | X | X | X | X | X | ||||||
SOFA score and OI | X | X | X | X | X | X | |||||
Clinical status | X | X | X | X | X | X | X | X | X | ||
PK sampling | X | X(m) | X(m) | X(m) | |||||||
Blood, plasma and serum sampling for biomarker studies | X | X | X | X | X | ||||||
Thoracic ultrasound (optional) | X | X | X | ||||||||
Targeted medication review (including use of vasopressors) | X | X | X | X | X | X | X | X | X | ||
Adverse event evaluation | X | X | X | X | X | X | X | X | X | X | |
SAFETY LABORATORY | |||||||||||
Hematology, chemistry, liver function tests, coagulation | X | X | X | X | X | X | |||||
Pregnancy test for females of childbearing potential | X |